# OnCo record napoli-1 (trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/trials/napoli-1/>
  a schema:MedicalTrial ;
  onco:kind "trial" ;
  schema:identifier "napoli-1", "NCT01494506" ;
  schema:name "NAPOLI-1"@en ;
  schema:alternateName "NAPOLI 1"@en, "MM-398 phase 3"@en ;
  schema:description "NAPOLI-1 gave pancreatic cancer its first licensed second-line treatment: liposomal irinotecan with fluorouracil extended median survival from 4.2 to 6.1 months after gemcitabine had failed, while the liposome alone did nothing. It is approved in the United States and Europe but NICE turned it down in 2017."@en ;
  schema:url <https://onco.cc/trials/napoli-1/> ;
  schema:dateModified "2026-09-24"^^xsd:date ;
  schema:citation <https://clinicaltrials.gov/study/NCT01494506>, <https://doi.org/10.1016/S0140-6736(15)00986-1>, <https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22ONIVYDE%22>, <https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal>, <https://www.nice.org.uk/guidance/ta440> ;
  onco:status "positive" ;
  onco:phase "3" ;
  onco:cancers <https://onco.cc/cancers/pancreatic/>, <https://onco.cc/cancers/metastatic-pdac/> ;
  onco:technologies <https://onco.cc/technologies/cytotoxic-chemotherapy/>, <https://onco.cc/technologies/topoisomerase-inhibitors/> ;
  onco:drugs <https://onco.cc/drugs/liposomal-irinotecan/>, <https://onco.cc/drugs/fluorouracil/>, <https://onco.cc/drugs/leucovorin/> ;
  onco:companies <https://onco.cc/companies/merrimack-pharmaceuticals/>, <https://onco.cc/companies/ipsen/> ;
  onco:terms <https://onco.cc/terms/pancreatic-cancer-uk-drug-access/> .